Elemental Formula Hypoallergenicity

June 24, 2013 updated by: Nestlé

Evaluation of Hypoallergenicity of an Amino Acid-Based Infant Formula

The primary objective of this clinical trial is to determine whether a new amino acid-based formula is hypoallergenic as defined by the American Academy of Pediatrics (2000), demonstrating that the test formula does not provoke allergenic activity in 90% of infants or children with confirmed cow's milk allergy (CMA) with 95% confidence as compared to a commercially available hypoallergenic formula.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Huntington Beach, California, United States, 92647
        • Pediatric Care Medical Group, Inc.
      • San Diego, California, United States, 92123
        • Allergy & Asthma Medical Group and Research Center, A P.C.
    • Georgia
      • Albany, Georgia, United States, 31707
        • Georgia Pollens Clinical Research Centers Inc.
    • Illinois
      • Hinsdale, Illinois, United States, 60521
        • Allergy & Asthma Physicians
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Deaconess Clinic, Inc.
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
      • Newburgh, New York, United States, 12550
        • ENT & Allergy Associates
    • Texas
      • Boerne, Texas, United States, 78006
        • TTS Research
    • Virginia
      • Richmond, Virginia, United States, 25233
        • Clinical Research Partners

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Born at term (>36 weeks gestation)
  • 2 months to ≤12 years of age at enrollment
  • Documented CMA within 6 months prior to enrollment
  • Otherwise healthy
  • Asthma, atopic dermatitis and/or rhinitis must be well-controlled, if applicable
  • Expected daily intake of at least 8 oz (240ml) of the study formula during the open challenge phase
  • Having obtained his/her legal representative's informed consent

Exclusion:

  • Children consuming mother's milk at the time of inclusion and during the trial
  • Any chromosomal or major congenital anomalies
  • Any major gastrointestinal disease or abnormalities other than CMA
  • Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay)
  • Immunodeficiency
  • Anti-histamine use in 7 days prior to the first food challenge (eyedrops are permitted)
  • Oral steroid use within 14 days prior to enrollment (intranasal and topical corticosteroid use are permitted)
  • Unstable asthma
  • Severe uncontrolled eczema
  • Severe anaphylactic reaction to milk within the last 2 years
  • Severe anaphylactic reaction to breastmilk within the last 2 years
  • Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol
  • Currently participating in another clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: New Amino Acid formula
Other: Amino Acid formula
Amino Acid baby formula
Active Comparator: Control formula
Commercially available Amino Acid infant formula
Other: Commercially available Amino Acid Formula
Hypoallergenic Baby formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
occurrence of allergic reactions
Time Frame: 14 days
occurrence of allergic reactions to double-blind placebo controlled food challenge (DBPCFC)
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Digestive Tolerance
Time Frame: one week
gastrointestinal tolerance and formula intake recorded during the open challenge phase.
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Anna Nowak-Wegrzyn, MD, Mount Sinai Department of Pediatrics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

March 30, 2012

First Submitted That Met QC Criteria

March 30, 2012

First Posted (Estimate)

April 3, 2012

Study Record Updates

Last Update Posted (Estimate)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 24, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.55.PED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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